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AzTrials

Kidney CancerPhase 2NCT06211790

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma

A Phase 2 study testing Anlotinib, Everolimus and Tislelizumab in people with Kidney Cancer and Renal Cell Carcinoma, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Based on different subtypes, subjects will be placed in one of three treatment groups to explore individual efficacy and safety of various treatment regimen. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib, Everolimus and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
16 Jan 2024to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet the following criteria are eligible to participate in the trial:
  • Male or female aged 18 and ≤ 75;
  • Histologically or cytologically confirmed unresectable or metastatic clear cell carcinoma of the kidney, which may contain sarcomatoid lesions;
  • At least one measurable target lesion at the time of enrollment according to RECIST1.1(Response Evaluation Criteria In Solid Tumors) standards;
  • Tissue samples are available for testing;
  • No previous systemic treatment for the disease;
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  • ECOG(Eastern Cooperative Oncology Group) PS(performance status) 0-1;
  • Normal function of major organs (14 days prior to enrollment), i.e. meeting the following criteria:
  • Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony were received within 14 days before enrollment Stimulator therapy) :
  • HB 90 g/L or higher The ANC(absolute neutrophil count) acuity 1.5 x 109 / L PLT(platelet count) acuity 100 x 109 / L
  • No functional organic disease, the following criteria should be met:
  • Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥40 mL/min T-bil ≤1.5×ULN upper limit of normal value ALT(Alanine transaminase) and AST≤2.5×ULN If liver metastasis, ALT and AST≤5×ULN
  • Expected survival ≥3 months;
  • Patients with potential fertility need to use contraception during the study period;
  • Patients who volunteered to participate in this study and signed informed consent.

Who cannot join

  • Patients with any of the following conditions will be excluded from the trial:
  • Patients who have received the following medical interventions in the four weeks prior to treatment:
  • Radiation, surgery, chemotherapy, immunotherapy or molecular targeted therapy for tumors
  • To participate in other clinical studies of drug therapy
  • Live attenuated vaccine history
  • Previously received PD-1/PD-L1 monoclonal antibody, CTLA-4 antibody(cytolytic T lymphocyte-associated antigen) or other immunotherapy;
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  • Previously received targeted therapy;
  • Definite brain/meningeal metastasis;
  • Patients who received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to enrollment;
  • Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Severe disturbances (CTCAE, Common Terminology Criteria for Adverse Events> Class 2) occurred within 4 weeks prior to administration of the study drug;Baseline chest imaging suggests active pulmonary inflammation, signs and symptoms of infection (unexplained fever >38.5 degrees) within 14 days prior to first use of the study drug, or the need for oral or intravenous antibiotic treatment;
  • Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to treatment, or with arteriovenous thrombosis events occurring within 6 months prior to treatment;
  • Active cardiovascular disease, such as myocardial infarction, severe/unstable angina, or New York Heart Association Class III or IV congestive heart failure, was present in the 6 months prior to treatment.
  • Have had other malignancies in the past 5 years (basal cell carcinoma of the skin that has been cured, except carcinoma in situ of the breast and carcinoma in situ of the cervix);
  • Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
  • Known to have active tuberculosis;
  • HIV antibody positive, active hepatitis B or C (HBV, HCV);
  • Is known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;
  • Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures;
  • In the investigator's judgment, there is a concomitant medical condition (such as poorly controlled high blood pressure, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

dingwei ye contact

18121299571

dwye.li@163.com

hailiang zhang contact

13524071783

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    dingwei ye

    Recruiting

Other trials in China

About this study

Official title: Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma: a Single-center, Prospective, Phase II Umbrella Clinical Study

Based on different subtypes, subjects will be placed in one of three treatment groups to explore individual efficacy and safety of various treatment regimen.

Read the detailed description

MSKCC Prognostic Model and IMDC(International Metastatic Renal Cell Carcinoma Database Consortium) Criteria are derived from cytokine and targeted therapy era, separately. In order to adapt to immunotherapy era and achieve the precision treatment in patients with kidney cancer, a new molecular typing map is urgent to be set up. In this study, patients with renal cell carcinoma will be divided into three types, FuDan-GP1(glycoprotein I) subtype (targeted sensitive type), FuDan-GP2(glycoprotein 2) subtype (Cold tumor) and FuDan-GP3(glycoprotein 3) subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs(tyrosine kinase inhibitor) and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications. Based on the gene proteomic analysis of tissue samples, a molecular typing map was set up and the efficacy and safety of anlotinib, anlotinib combined with everolimus, and anlotinib combined with tislelizumab in the first-line treatment of unresectable or metastatic renal clear cell carcinoma will be evaluated.

Being tested
Anlotinib, Everolimus and Tislelizumab
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib, Everolimus and TislelizumabDrug

    Anlotinib (PO, QD), Everolimus (PO, QD) and Tislelizumab (IV, Q3W)

Study groups in NCT06211790
Study groupRoleWhat they receive
FuDan-GP1 subtypeExperimentalFuDan-GP1 subtype is targeted sensitive type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off.
Receives: Drug: Anlotinib, Everolimus and Tislelizumab
FuDan-GP2 subtypeExperimentalFuDan-GP2 subtype is Cold tumor type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with everolimus 5 mg PO, QD.
Receives: Drug: Anlotinib, Everolimus and Tislelizumab
FuDan-GP3 subtypeExperimentalFuDan-GP3 subtype is progenitor infiltrating type. Treatment regimen：anlotinib 12 mg PO, QD, 14 days on - 7 days off combined with tislelizumab 200 mg, IV, Q3W.
Receives: Drug: Anlotinib, Everolimus and Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    ORR(objective response rate) is defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1.

    Measured: 6 months

Secondary outcomes (2)

  1. Progression Free Survival

    PFS(progression-free survival), defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first)

    Measured: 3 years

  2. Overall Survival

    OS(overall survival) is defined as the time from the date of randomization to the date of death from any cause.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start16 Jan 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
patients with renal cell carcinoma will be divided into three types, FuDan-GP1 subtype (targeted sensitive type), FuDan-GP2 subtype (Cold tumor) and FuDan-GP3 subtype (progenitor infiltrating type) in accordance with the condition of response to TKIs and the infiltration of immune cells, which dates from previous protein genomics study published by Nature Communications.
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211790
Sponsor's protocol ID
Upcoming
Status last verified
Jan 2024
First submitted
3 Jan 2024
Last updated
18 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib, Everolimus and Tislelizumab in people with Kidney Cancer and Renal Cell Carcinoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact dingwei ye (18121299571, dwye.li@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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